Kris DeVault is not giving up. His son Brody, born in March 2023, showed early signs of developmental delay. At two and a half, a genetic test confirmed the diagnosis. There is a therapy — but it is not approved. Montana just passed a new "right to try" law letting terminal patients access experimental treatments that are not FDA-approved. For the DeVault family, it is a door opening. For Europeans, it is a punch in the gut.
Why it matters. In the US, the federal Right to Try Act has existed since 2018. It allows access to investigational drugs that have passed Phase 1 — meaning they are reasonably safe, but not yet proven. Montana's new law adds a faster access track for those who have no time to spare. This is not about "America vs Europe." It is about something more uncomfortable.
In Europe, and especially in Italy, access to experimental drugs is a maze. You need the national medicines agency's approval, an ethics committee's opinion, hospital-level procedures. It takes months. For a patient with a degenerative disease, months are a death sentence. This is not about safety: safety should be evaluated case by case, not by a bureaucracy that protects administrators more than patients. It is about priorities. The European health system is built for the average user, not for a person with a rare disease. And anyone with a rare disease in Italy knows it: you become an expert in regulations, not in treatments.
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Our position is clear: prudence cannot become a barrier, and results are measured on patients
We, at Meteora Web, come from a world where results matter: revenue, conversions, margins. We have managed an ERP system for a clothing retailer; we know what it means to look at numbers and make decisions. The current Italian system for experimental therapies is like a website that loads in 6 seconds: technically functional, but it loses customers. The American "right to try" shifts the balance from theoretical risk to real need. It is not anti-science — it is a change of priority. Instead of protecting the system, it protects the person. Europe, with its architecture of committees, prefers to protect the procedure. The result? Italian families who can afford it go abroad: Switzerland, the US, Germany. The others wait.
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Do not misunderstand us. We are not asking to abolish clinical trials or to trust the promises of a biotech startup. We are saying that the "bureaucracy first, patient second" paradigm is too costly. And technology matters here. Today we have tools to monitor every single patient in real time: wearables, genetic data, electronic health records. We can gather more data in one year of compassionate use than in five years of a standard trial. Yet we keep acting as if the only source of truth were a randomized study from ten years ago. The world has changed. Regulation has not.
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What to do. If you are an entrepreneur, a developer, a professional in Italy, the principle is the same one we apply every day: measure outcomes, not process. Demand that your representatives in Europe and Italy ask for a regulatory agency that responds in weeks, not months. Support patient organizations pushing for early access. And if you work in health-tech, build solutions that collect real-world patient data — not tools that feed bureaucracy. Data is the new drug. Used well, it saves lives. Used to defend the status quo, it loses them.
